Summary

Early, strategic IP planning is becoming as vital as scientific discovery itself — and the smartest innovators are treating patents as part of their R&D roadmap, not an afterthought.

At a recent roundtable hosted by industry leaders, experts from pharma, biotech, and academia explored how early, well-planned IP strategies can shape the commercial trajectory of novel therapeutics. Discussions covered the timing of filings, the distinction between platform and product patents, and the evolving challenges faced by startups and universities in protecting innovation.

 The Early Conversation: “You Can’t Start Too Soon”

In today’s biopharmaceutical arena, the race to innovate is matched by the race to protect. From biologics and ADCs to RNA-based therapies, intellectual property (IP) defines a company’s ability to attract investment and secure exclusivity.

At the Roundtable Discussion on “IP Considerations in Early Discovery & Development”, experts across the ecosystem—from IP attorneys and startup founders to scientists and technology transfer officers—agreed that IP strategy must begin as early as discovery.

“You can’t start too early,” said one patent attorney. “Even if you file later to extend your patent term, you should be thinking about IP protection from day one.”

For large pharma like Pfizer or AbbVie, delaying filings can help preserve the 20-year patent term while internal systems manage disclosure risks. But for smaller biotechs, the calculus differs: early filings often determine whether they can secure funding and establish credibility with investors.

 Timing, Disclosure, and Risk

Early filing brings both advantages and risks. Filing too soon can expose proprietary targets and mechanisms before a company is ready. But waiting too long can forfeit novelty and ownership.

Provisional filings offer a pragmatic solution. They establish a priority date while delaying full disclosure for up to a year, allowing time to validate data and refine strategy.

However, as one participant cautioned, “Abandoning a patent after it’s been disclosed publicly can be fatal. Once published, it becomes prior art—even against your own future filings.”

 Platform vs. Product: Getting the Order Right

Another key debate centered on the distinction between platform patents—technologies such as linker systems, delivery vehicles, or gene-editing methods—and product-specific patents covering the drug candidate itself.

If filed in the wrong order, a molecule-specific patent can inadvertently block future platform claims.

“File the platform first, or at least concurrently,” an IP specialist advised. “Otherwise, your own patent can become prior art against you.”

For startups, broad platform IP often serves as their primary asset; for large pharma, it’s a strategic tool that can open opportunities for licensing or collaborations. Both require a delicate balance between scope and support—broad enough to deter competition, but specific enough to survive examination.

 Building the “IP Fence”

The discussion turned to portfolio layering, the practice of surrounding a core composition-of-matter patent with secondary protections. These may include:

  • Formulation and delivery patents
  • Manufacturing processes
  • Therapeutic indications and dosing regimens
  • Combination therapies or follow-on uses

This “IP fence” can significantly extend commercial exclusivity. AbbVie’s Humira was cited as a prime example, supported by more than 100 patents covering every aspect of the product lifecycle.

“Layered patenting isn’t just defensive—it’s about maintaining flexibility,” one scientist noted. “Each new filing adds protection and value as the drug matures.”

 Extending Patent Life: PTEs and PTAs

Panelists also discussed mechanisms for formal patent extensions.

  • Patent Term Extension (PTE) compensates for regulatory review delays (e.g., FDA approval).
  • Patent Term Adjustment (PTA) extends protection if the U.S. Patent and Trademark Office takes too long to process applications.

Both strategies can provide critical months—or even years—of additional market protection, though they differ from the broader practice of portfolio layering.

Universities and the Funding Gap

Representatives from academic institutions offered a different perspective. University researchers often generate early-stage innovations—new targets, mechanisms, or pathways—but lack the funding to maintain patents until commercialization.

“A lot of university IP never leaves the shelf,” said a technology transfer officer from the University of the Witwatersrand in South Africa. “Without a licensee or funding, even strong patents lapse before they can make an impact.”

To attract partners, universities often file broad, concept-driven patents, hoping to appeal to multiple licensees. Yet these can face higher rejection rates due to insufficient data or broad claims, making prosecution costly and lengthy.

 Choosing Where to File: Global Strategy, Local Budgets

Filing internationally can be prohibitively expensive, especially once the PCT application enters national phase around 30 months after the initial filing. Experts recommended a tiered jurisdictional strategy:

  • Tier 1: U.S., Europe, Japan, China — key markets and manufacturing hubs.
  • Tier 2: Secondary markets with moderate commercial interest.
  • Tier 3: Defensive filings in limited jurisdictions to block competitors.

Startups should plan for these costs early, as investors often expect visibility on global IP strategy.

 Manufacturing Know-How: The Hidden Advantage

For biologics and ADCs, manufacturing processes can serve as powerful, less-visible IP. Patents covering cell lines, conjugation chemistry, or purification methods are difficult to design around and can effectively deter biosimilar competition.

“Sometimes your biggest advantage isn’t the molecule—it’s how you make it,” a participant observed. “Manufacturing IP can be a fortress of its own.”

 From Concept to Commercialisation

By the session’s close, participants aligned on one key insight: IP strategy must evolve hand-in-hand with scientific discovery. For startups, it’s the foundation for fundraising; for large pharma, it’s the roadmap to sustained exclusivity; and for universities, it’s a bridge between research and real-world application.

“Patents aren’t just about protection—they’re about positioning,” concluded one panelist. “They define how your science becomes a business.”

 The Takeaway

In an industry where discovery moves fast and competition is global, IP is no longer a box to check at the end of development—it’s a strategic discipline woven into every stage of innovation.
The companies that think about IP earliest are often the ones still standing when the rest are fighting for freedom to operate.